Excessive regulation of DTC genomics will come at a cost

Caroline and I have an opinion piece in this week’s New Scientist arguing that regulators should consider the benefits of personal genomics (in terms of increasing genetic literacy and innovation) before imposing excessive regulation on the direct-to-consumer genetic testing industry. Here’s the take-home message:

We don’t yet know what role personal genomics will play in the future of medicine. However, we do know that it has great potential for innovation and education, and we must ensure that neither excessive regulation nor medical paternalism get in the way.

Unfortunately due to space restrictions several sections of our argument were cut – for instance, we spent some time arguing against the idea of arbitrary divisions of tests into “medical” and “non-medical” categories, with the former requiring supervision of a medical professional to receive results. Here’s the original wording:

Unlike many commentators, including the HGC, we do not support an unsustainable division of tests into separate categories, one for health-related tests that require counselling from a medical professional and another for everything else with no such requirement. It is hard to justify the argument that results suggesting a mildly elevated predisposition to obesity require a professional intermediary to provide support, while those indicating unexpected paternity do not.

In general, we would argue that people should be free to access their own genetic data unless there is good reason to believe that doing so will cause them real harm – and as long as the information is accurate and transparent. Companies should ensure that customers have access to expert advice if they want it, but medical supervision should not be a requirement for access to your own genome.

But three things argue against wholesale regulation. First, the level of interference needs to be based on the level of risk a test represents. The government does not need to be involved if someone decides to trace his ancestry or discover what type of earwax he has. Second, the laws on fraud should be sufficient to deal with the snake-oil salesmen who promise to predict, say, whether a child might be a sporting champion. And third, science is changing very fast. Fairly soon, a customer’s whole genome will be sequenced, not merely the parts thought to be medically relevant that the testing companies now concentrate on, and he will then be able to crank the results through open-source interpretation software downloadable from anywhere on the planet. That will create problems, but the only way to stop that happening would be to make it illegal for someone to have his genome sequenced—and nobody is seriously suggesting that illiberal restriction.

Instead, then, of reacting in a hostile fashion to the trend for people to take genetic tests, governments should be asking themselves how they can make best use of this new source of information. Restricting access to tests that inform people about bad reactions to drugs could do harm. The real question is not who controls access, but how to minimise the risks and maximise the rewards of a useful revolution.

It’s great to see these issues getting sensible discussion in the wider media; let’s hope the FDA is paying attention.

6 Responses to “Excessive regulation of DTC genomics will come at a cost”

A key thing to keep in mind is that the FDA, like all bureaucracies, is a political entity which only pays attention to those who can put its jobs, reputations, or funding levels at risk. This means print and TV news coverage criticizing bureaucrats by name for specific policy actions.

Avastatin is a good example. The Wall Street Journal piece on Avastatin hit them hard and even Rob Steinacknowledges this has become a political issue.

On Monday, Rob Stein of the Washington Post noted cost considerations may play a part in the FDA’s decision:

The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?

He adds: “The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment.”

The most substantive development in FDA regulation is probably not going to be sweet reason. It is instead likely to be the November 2 election, which by all indications is going to be a Republican rout rivaling 1994. For non-Americans, this will give some idea of the feeling in the country now.

In the immediate aftermath of 1994, a slogan that achieved much currency was “If a murderer kills you, it’s homicide. If a drunk driver kills you, it’s manslaughter. If the FDA kills you, it’s just being cautious.”

If the FDA kills genomics and LDTs, it will do so it because it is “being cautious”, because there is no political penalty for doing so. Until, perhaps, November 3.

Despite its hyped public persona, genetic testing is STILL in a VERY primitive, crude, imprecise state for now, not just prone to misinterpretation, but virtually guaranteed of misinterpretation and abuse. Government regulation is a necessary evil, because the alternative, already driving this debate, remains the greater evil of corporate greed. Pharmaceutical companies practice few ethics in pushing their (prescription-only) products via TV ads, and the only ethics the DTC companies will succumb to are those imposed and ENFORCED by regulation (they’ll do an end-run around the unenforced ones, as they already do). It’s naive and pollyannish to think otherwise.

DTC companies are already subject to regulation: CLIA standards for lab quality control, and consumer protection laws governing false advertising. Those existing laws, if refined and properly enforced, would be enough to drive out the outright scammers from the industry.

The question is whether the FDA needs to get involved as well. Intriguingly, over the last two years, the major personal genomics companies have created and marketed scientifically valid products without any engagement from the FDA. Tight FDA regulation would cause harm (by creating obstacles to innovation, and obstructing people’s access to their own genetic information) that IMO would substantially outweigh the gains.

The key thing that is required here is transparency, not regulatory obstacles: if companies are forced to release the markers and algorithms used, and the scientific evidence underlying their claims, it will be straightforward for experts to critique their products and provide guidelines for consumers.

Also worth noting that the major DTC genetics companies have been practically begging for clear govournment regulation and guidelines of their tests for years now. As I have discussed on this blog before, everyone wants regulation, the debate is down to whether these products are regulated as medical/diagnostic tests, or as consumer products.

Hey Luke, it’s not so much that the companies wanted new rules, it’s that they didn’t want to deal with fifty different state laws. But no one wanted this kangaroo court spectacle, nor the idea of jamming everything new into outmoded regulatory paradigms. Also, startups can’t speak freely and say that the regulators are off their rocker because the government has the guns and will crush them with fines and citations for open opposition. Just see how the police react to being videotaped and you’ll get a sense of how the Food & Drug police react to criticism. Regulators are literally police with all that entails.